Quality of life instruments in studies of menorrhagia: a systematic review T. Justin Clark a,* , Khalid S. Khan a , Richard Foon a , Helen Pattison b , Stirling Bryan c , Janesh K. Gupta a a Department of Obstetrics and Gynaecology, Birmingham Women’s Hospital, Birmingham BI5 2TG, UK b Department of Primary Care, Birmingham University, Birmingham, UK c Department of Public Policy and Health Services Management, Birmingham University, Birmingham, UK Abstract Background: The use of quality of life (QoL) instruments in menorrhagia research is increasing but there is concern that not enough emphasis is placed on patient-focus in these measurements, i.e. on issues which are of importance to patients and reflect their experiences and concerns (clinical face validity). The objective was to assess the quality of QoL instruments in studies of menorrhagia. Study design: A systematic review of published research. Papers were identified through MEDLINE (1966–April 2000), EMBASE (1980–April 2000), Science Citation Index (1981–April 2000), Social Science Citation Index (1981–April 2000), CINAHL (1982–1999) and PsychLIT (1966–1999), and by manual searching of bibliographies of known primary and review articles. Studies were selected if they assessed women with menorrhagia for life quality, either developing QoL instruments or applying them as an outcome measure. Selected studies were assessed for quality of their QoL instruments, using a 17 items checklist including 10 items for clinical face validity (issues of relevance to patients’ expectations and concerns) and 7 items for measurement properties (such as reliability, responsiveness, etc.). Results: A total of 19 articles, 8 on instrument development and 11 on application, were included in the review. The generic Short Form 36 Health Survey Questionnaire (SF36) was used in 12/19 (63%) studies. Only two studies developed new specific QoL instruments for menorrhagia but they complied with 7/17 (41%) and 10/17 (59%) of the quality criteria. Quality assessment showed that only 7/19 (37%) studies complied with more than half the criteria for face validity whereas 17/19 (90%) studies complied with more than half of the criteria for measurement properties (P ¼ 0:0001). Conclusion: Among existing QoL instruments, there is good compliance with the quality criteria for measurement properties but not with those for clinical face validity. There is a need to develop methodologically sound disease specific QoL instruments in menorrhagia focussing both on face validity and measurement properties. # 2002 Elsevier Science Ireland Ltd. All rights reserved. Keywords: Menorrhagia; Quality of life; Systematic review 1. Introduction Menorrhagia, defined as blood loss of 80 ml or more per period, is a common problem in both gynaecological and general practice. One in five women undergo hysterectomy by the age of 60 years [1], the majority of them have menorrhagia with no detectable pelvic pathology. This, along with the high cost associated with medical manage- ment, means that menorrhagia places a huge financial burden on the health service [1]. The overall aim of manage- ment of chronic, benign conditions such as menorrhagia is to reduce the adverse impact of the condition thereby improv- ing the sufferer’s ‘quality of life’ (QoL). This has led to the increasing development and use of instruments to measure life quality in menorrhagia research. It has increasingly become apparent that the threshold for managing menorrhagia is determined by patients’ expecta- tion, not by measurement of blood loss during a period. First of all, such measurements are not practical in routine practice [2]. Moreover, they do not always correlate with women’s personal perception of menstrual loss. Thus, the use of QoL instruments in menorrhagia research is increas- ing to allow more objective assessment of clinical outcomes of therapeutic interventions. Although generic QoL instru- ments have been developed for application in a general population, QoL measurement cannot ignore aspects that are unique to the medical condition being assessed. Thus, disease specific instruments are required to obtain patient focussed measurements. Research in menorrhagia can employ both generic [3] and disease specific [4,5] QoL instruments (see definitions in the subsequent sections). European Journal of Obstetrics & Gynecology and Reproductive Biology 104 (2002) 96–104 * Corresponding author. Tel.: þ44-121-472-1377; fax: þ44-121-627-2667. E-mail address: t.j.clark@bham.ac.uk (T.J. Clark). 0301-2115/02/$ – see front matter # 2002 Elsevier Science Ireland Ltd. All rights reserved. PII:S0301-2115(02)00076-3